Q2 2025 TG Therapeutics Inc Earnings Call
Greetings, welcome to TG Therapeutics second quarter earnings call and webcast.
At this time, hope to spend some time listening mode.
The question-and-answer session will follow the formal presentation.
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Please note this conference is being recorded.
At this time I'll turn the conference call over to Jenna Bosco Chief Communications officer Jenna you may now begin.
Thank you, and welcome everyone. Thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter 2025 financial results is Michael Weiss, our Chairman and Chief Executive Officer.
Adam Waldman, our chief commercial officer and Sean power, our Chief Financial Officer.
Following our Safe Harbor statement. Mike will provide an overview of our recent corporate development.
Atom will share an update on our commercial efforts, and Sean will give a summary of our financial results for Q4. Turning the call over to the operator to begin the Q&A session.
before we begin I would I would like to remind everyone that we will be making forward-looking statements within the meeting of the private Securities, litigation Reform, Act of 1995,
These forward-looking statements include statements about our anticipated. Future operating, and financial performance, including sales performance projected Milestones Revenue guidance development, plans, and expectations for our marketed products.
PG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicators.
Factors that may affect TG Therapeutics operations. Include various risk factors that can be found in our SEC filing.
In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date.
We specifically disclaim any obligation to update or revise, any forward-looking statements.
This conference call is being recorded for audio rebroadcast on T's website at www.tgtherapeutics.com, where it will be available for the next 30 days.
Now, I would like to turn the call over to my wife, our CEO.
Thank you, Jenna, and good morning everyone. Thank you for joining us. On today's call, I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business.
highlighted by the continued momentum of our flagship product for young beef.
The ongoing enthusiasm from the MS Community, has been both gratifying and energizing and our commercial performance has exceeded expectations.
At TG our missions to bring forward therapies that truly improve the lives of those living with multiple sclerosis.
Hearing real world stories from individuals. Ombre is both validating and deeply inspiring.
Mb.com to hear some of these patient experiences firsthand.
Our commercial team remains disciplined and highly effective in executing our multi-year launch strategy.
As a result, adoption continues to grow now, approximately 2 and a half years into launch. We estimate that nearly 1 in every 3 new IV anti-CD20 patients are prescribed Bonzi. This represents meaningful progress toward our long-term goal of making Bonzi the most prescribed anti-CD20 therapy for relapsing MS, as measured by dynamic market share.
And as adoption continues to grow, we remain focused.
On expanding choice and flexibility for patients and providers, through the development of subcutaneous brownie and our enhanced study, the development of subcutaneous brownie represents a strategic opportunity to further build a leadership role in the anti-CD20 space.
If approved, subQ Brownie would significantly expand our addressable market by unlocking access to 35% to 40% of the anti-CD20 dynamic market segment that currently prefers a self-administered option.
Of which only 1 is available today.
We believe SubQ Bondi has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position TG as the only company offering both an IV and a self-administered option, potentially simplifying the treatment decision for patients and providers and positioning Bonnevie as the anti-CD20 therapy of choice.
Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal Phase 3 trial for subQ Bombi in the coming weeks.
This study will evaluate two dosing schedules: every other month and quarterly, compared to Ivy, Brownie, and patients with relapsing forms of MS.
The primary endpoint is to demonstrate. Non-inferior exposure between subq dosing and our approved IV dosing.
We anticipate completing enrollment in 2026.
Filing a bla in 2027.
And pending approval, we are launching a subcutaneous therapy in 2028.
At the same time, we're focused on enhancing the patient experience with IV Burani.
A pleased to report that within the enhanced trial. We have begun enrollment into a randomized, double blind phase 3 cohort, evaluating the potential to consolidate the day, 1 and day 15, infusions into a single 600 mg infusion on day 1.
The goal of this study is to establish comparable exposure between the two dosing schedules.
If successful, this simplified approach would eliminate the need for a second infusion and the first two weeks offering, which we believe would provide a meaningful convenience benefit for patients and infusion centers.
We look forward to pivotal data in 2026 with the goal of an updated label in 2027.
Turning briefly to our pipeline, we are also pleased to share that we have dosed our first patient with progressive MS using Azercell, our investigational allergenic.
Cd19 directed carti therapy.
In parallel, we continue to explore the use of Bambi in myasthenia gravis, as we consider additional opportunities to expand the uses of BMD.
This is an exciting time at TG. Our results of this quarter reflect strong execution across both commercial and clinical funds, and a growing confidence in BLA from physicians and patients alike.
With continued progress on our subq program enhancements to the ivy experience.
And the advancement of our cd19 car seat into the clinic. We're laying the groundwork for sustained leadership in the MS. Space.
With that.
I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead.
Thank you, Mike, and good morning, everyone. I'm excited to report that Q2 2025 was another strong quarter for TG Therapeutics.
Hub, since launch.
We're now seeing the tangible results of our strategic investments, as the foundation we've built continues to scale.
Us net sales for bham being Q2 totaled, approximately 139 million ahead of our. Our internal expectations and building on the robust growth. We achieved in q1, positioning us for a strong second half of 2025.
Several key performance drivers reinforce our confidence in the brands' continued trajectory.
We saw a meaningful increase in both new prescribers and new accounts, reflecting deeper penetration across academic institutions and community neurology practices.
Q2 marked our highest volume of new patient enrollments to date, a clear indicator that our reach is expanding and that awareness among providers and patients is accelerating.
We also continue to observe strong persistence and repeat prescribing.
Which we view as a validation of, Bambi's differentiated clinical profile and its value in real world practice.
Today, the CD20 class generates over $8 billion in annual U.S. sales and continues to grow.
Bring on the is steadily increasing its share within these expanding markets.
As Mike mentioned earlier, we estimate that nearly one-third of new patients initiating IV anti-CD20 therapy are being prescribed Bambi.
We Believe The Remains significant Headroom for continued growth for the class and for BMV within it.
Our competitive advantage remains clear and convenient: twice a year, 1-hour infusion.
Combined with five-year safety and efficacy data, collectively offers a compelling treatment option for MS patients.
The differentiators continue to resonate strongly with care settings from large academic centers to private practices, to the VA system where we continue to be the preferred anti-cd20 therapy.
A major milestone in this quarter was the launch of our first ever National Television campaign. This initiative is part of a broader multi-channel strategy that will ramp throughout the second half of the year with the goal of driving patient awareness.
While it's still early, we're seeing promising signs of the investment as having an impact.
Our latest market research shows a measurable uptick in patient, awareness of Brandy.
Website traffic, branded organic search impressions, branded paid search impressions, and qualified visitors to the website have all increased meaningfully.
And importantly, Physicians are reporting more patients, requesting BMV by name.
We are closely tracking key performance indicators across media channels and will continue to monitor performance.
But early signals are encouraging.
I also want to highlight the efforts of our commercial team. We believe we have a highly effective field team, and our recent surveys backed that up with consistently high ratings when compared to our peers in the MS space.
Their ability to clearly communicate Bri's value proposition is a key part of our strategy, and their daily commitment is making a real difference.
Looking ahead. We are confident in the continued growth of Brandy revenues based on current trends in both new patient prescriptions and Persistence of existing patients. We are again raising our full year us, bring up the net revenue guidance, which was 560 million, to 570 to 575 million for the full year 2025.
Similar to last year, uh, given expected Q3 seasonality. We would expect stronger growth, Q3 to Q4 than Q2 to Q3.
With multiple growth drivers in place, expanding patient and prescriber bases, increasing brand recognition, and the momentum of our media investments, we believe Brillanti is on track to become a multi-billion dollar brand in relapsing MS.
To summarize, Q2 was another quarter of commercial strength, execution, and strategic progress. We expect a strong second half of the year with that. I'll turn it over to Sean to walk through the financials.
Thank you, Adam and good morning everyone.
Earlier this morning, we reported our detailed second quarter 2025 financial results via press release, which is available in the investors and media section of our website.
Let's start by thinking of closer. Look at our revenue performance, which continues to demonstrate strong growth and commercial momentum.
We're very pleased to report total revenue of $141.1 million for the second quarter of 2025, which includes net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and 16% growth over the first quarter of this year.
Performance reflects the continued uptake and demand for Brandy and highlights our team's success and execution across the commercial landscape.
Additionally, we recorded $2.3 million in license milestone and royalty revenue this quarter.
Turning to our expenses, our total Opex, defined as R&D and SG&A costs, excluding non-cash compensation.
Totaled approximately $71 million for the second quarter of 2025.
This represents an increase from 46.9 million in Q2 of 2024, but a decrease of about 10 million compared to the 4 first quarter of this year.
The year-over-year increase was primarily driven by ongoing investments in R&D, particularly related to the development of a subcutaneous formulation of BMB.
As well as our continued commercial efforts on the SG&A side.
In contrast, the sequential decline from Q1 was largely due to the timing of subcutaneous B on the development activities, which we expect will continue to have some quarter-to-quarter variability.
With all that said we continue to to expect full year operating expenses.
To be in the range of approximately 300 million in line with our prior guidance.
On the bottom line, we're pleased to report GAAP net income of $28.2 million, or $0.17 per diluted share, for the quarter ended June 30, 2025, as compared to $6.9 million in net income, or $0.04 per diluted share, for the second quarter of 2014.
And finally, a quick note on our balance sheet: we closed the quarter with approximately $279 million in cash, cash equivalents, and investment securities.
Which is essentially flat from the first quarter.
We believe that a strong capital position enables us to continue executing on our long-term strategy while preserving flexibility for future investments in our pipeline and operations.
In summary, the second quarter was a success on multiple fronts, with strong results both operationally and financially.
With that, I will now turn the call over to the conference operator to begin the Q&A.
Thank you at this time, we'll be conducting a question and answer session.
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1 moment, please while we pull for questions.
Thank you. And our first question is from the line of Tara. Vancross with TD count, please receive your questions.
Hi, good morning, and thanks for taking the questions. So I'm curious about the guidance; you know, it implies a little bit of leveling off of growth in the back half of the year. So I'm curious to get your thoughts and a bit more elaboration on what various headwinds and tailwinds we could expect in Q3 and Q4 to get a better idea of the cadence for the rest of the year. Thanks so much.
Sure, uh Adam uh, take that 1.
Sure, thanks for the question Tara. Um, you know, here we're raising guidance here and and um, as I mentioned in the prepared remarks, you know, we do see seasonality in the summer. Um,
We accounted for that and the guidance, and we expect stronger growth from Q3 to Q4. Um, and I think the, uh, success we've had in the first year with increasing enrollments and persistence in week, 24, and weak, 48 are driving our need to increase the, uh, the overall guidance for the year.
Okay, thank you.
Our next question is are from the line of Michael Dior with evercore isi.
Please receive with your questions.
Hey guys, uh, thanks so much for taking my questions and congrats on the strong quarter. Uh, just two for me. I was wondering if you could expand upon comments you recently made at a broker conference where you said that 40% of City 2020 new starts now opt for an at-home subQ. My question is, how would you say the remaining 60% is broken down in terms of those opting for BMV?
Versus the other competitors, Ivy, and subq for relations. And second question is, uh, just given the the growing payer push um, for lower cost at home therapies. Like are you seeing any early signs that the demand for subq could actually outpace ivy?
Payers could accelerate that shift uh in the next year or 2. Thank you.
Thanks, Mike. Um, Adam, do you want to give a crack here? I could always add on. But I think this one is right here: Warehouse.
Yeah, sure. Um, thanks for the question, Michael. So, the first question on the 60% that are IV, as I mentioned, uh, we, we believe in the IV segment or physician administered segment. We're capturing about 1 out of every 3 patients today. Um and uh the other competitors are are getting the other. The other part of that market um, as far as the pair questions, we're not seeing it today but certainly
Uh we could see it um it's it's certainly possible. Uh hence the reason we are, we are actively developing our own subq to participate in that that's a segment of the market.
Thank you.
The next question is from the line of secure and Jenkins with Goldman Sachs. Please proceed with your questions.
Good morning. Um, maybe could you talk a little bit more about the administration of the September hearing? This product, you're developing with the auto injector or pre-filled string engine, what additional work do you need to do on the device side? Um, in terms of getting that uh the development
Carried out the phone. Thanks.
Yeah, sure. Thanks for the question. So, um, yeah. So, as typical for these kinds of programs, the, uh,
The main study will be conducted with the, uh, with basically a syringe pulled from a vial, uh, to get the bioequivalence. And then there's usually a bridging study to either pre-fill syringe and, or to an auto injector. I think our plan is probably just go straight to the auto injector, uh, and so, there'll be a bridging study, that's part of the program. Um, but that's all sort of in the timelines that we provide in terms of our Target, uh, for a filing, uh, in in 27 and, and hopefully, uh, an approval on 28. But yeah, it starts off as uh,
Injections from a vial and then Bridges to the auto injector, uh, the auto injector. We're we're using is a, I call it relatively standard, it's been in.
You know, tens of thousands of patients in multiple drug launches—multiple major drug launches. Uh, so it's...
a pretty well known. Pretty pretty well accepted auto injector. Uh, and you know, I think, you know, there's the basic development that goes along with that. But I don't think, I don't think we're expecting any technical challenges with the auto injector.
Thank you.
Got it.
My next question is from the line of Maya, Quant, Tommy with B Riley Securities, pleased to see if your questions
Yes, good morning DS, for taking a questions and congrats on the progress, 1 more on the second half Revenue guidance. Could you touch on how you're assuming uh the anti-c 20 Ivy overall market trends including uh your belief on how new patients starts might be trending uh for zenova. And then I have a quick follow up.
Adam, you want to go ahead on this 1 too.
Sure.
Yeah, thanks for the question, Mike. Uh, you know, we're not we're not seeing uh, a lot of enthusiasm for the zenova product in the US. Um, you know, we continue. I think the, the biggest Point here is that we continue to grow. Uh, new patient enrollments. We've continued to grow through the launch. We've continued to grow through, um, you know, the ASP or the I'm sorry. The, uh, the J Code, the total of J Code. That was, that was granted in April, so we're not really seeing any impact on us. In terms of, you know, there's a Novo product. Um, and we're seeing overall limited enthusiasm for that for that, uh, uh, that that drug
And the overall Market you think is stable uh for for IV and and steadily growing or or it's just flat, can you comment on that atom?
Yeah, sure it's about. I think it's it's leveled out here at about 60, 60 40 6535.
Okay, thank you. And then on Extreme uh believe in the same session. We are getting this 6 year ultimate 1 and 2 trial data set. We are also getting the anti-cd19. Carti, I believe a single Center primary Progressive, uh, you know, early data set Mike, any any thoughts on what your expectations are with some of the early human data that could inform your own Azure cell development
Terms of anyone thinks they're going to do something.
Relatively quickly there, they're probably, you know, maybe off base, but we'll see. But anyway, yeah, I don't think there's going to be too much. It's going to change how we think about how we're developing the drug. I think we've got a pretty clear focus on what we want to achieve, uh and we'll see if we get there.
Thank you, Mike.
Thank you.
Our next question is from the line of Roger s with Jeffrey's please receive with your questions.
Hi. This is Roger. I had a question about whether you could touch on, uh, product appearance between the biyen. Infusions and then, my second question is and maybe I missed this. If you could give uh, 32 guidance, perhaps I missed that in the beginning of your call.
Yeah, I I go ahead.
Can you can you can you please repeat the second half of that question?
Uh, so about 32 items.
Yeah, sorry, I didn't hear the last part of it.
Potentially, I missed it. But did you guys give 3 to 5 businesses? If not? Could you give some color on that?
Uh, yeah, no, we did not give 32 guidance or Q3 guidance. We we are giving fully your guidance similar to what we did last year, uh, we gave you insight into what we feel is the the girls Trends from Q2 to Q3 and, and Q3 to Q4, but we we're not giving specific Q3 guidance here.
Okay. Thanks and then can you give us some color on the product appearance part for the uh sure in between the indigenous? Thank you.
Sure. I mean, what we've, what we've seen is that our persistence continues to be good, both at week 24. And, and, and we're getting preliminary data here at week 48. Uh, continues to be above our expectations, and, you know, slightly above where we would expect it to be based on public data. That's out there.
for other CD 20s, that is
Okay, thank you.
Thank you. The next question is from the line of parkar aural with kandare for Cheryl pleased to see you with your question.
Hi. Um, thanks for taking my question and congrats on the quarter again. Um, so firstly on the subk, it seems that you're also comfortable with the quarterly losing here. Maybe if you can comment, what you saw in Phase 1 for the quarterly dozing frequency and, uh, what will be injection volume for both quarterly, and every other month to do things.
Um also when can we see the sub cute Phase 1 data.
And how to follow up.
And enjoy the follow-up. Okay. Um, thanks brocker for the question, uh, on the subq dosing. Uh, yeah. I mean, look, we in terms of quarterly dosing, and and monthly, and every other monthly dosing, uh, you know, we've we've we've got preliminary by availability information, that leads us to believe that uh, that both
Are achievable certainly every other month uh and quarterly as well. Uh, we haven't provided that information just yet. Uh, in terms of volume, typical Auto injectors Max, you know, basically 2 MLS a volume, uh, so we'll probably be pretty close to that. Um, but yeah, I think and for the moment what we've said is, you know, we're comfortable that what we've seen with the B availability. It should support every other month, and and as I say in the prayer remarks, uh, potentially quarterly as well.
And you have a follow-up, you offer. Yep. Got it. Thanks. Thanks Mike. Uh, so on the on the second quarter, sequential growth of 16% how much is volume versus pricing and if you can comment on the growth tonight trends for the rest for the year.
Thank you so much.
Sure. You got it. I think that's it. 1 over Adam.
Sure. Oh, thanks for the question Proctor. You know what, on the girls and that I'll take that first, you know, we've guided 70 to 75% for the year and that, that Still Remains intact. I would say this quarter was it was probably closer to 70. Um, and the reason for that is that we we uh, our fastest growing segment is the hospital segment. Um, and we continue to see growth in in that uh, the segment of the market. And with that, you know, comes, uh,
Mandated government discounting or more exposure to government mandated discounting like, 340b discounting which can can affect your uh, your your gross in that. So so we did see gross, net, probably closer to 70 in this quarter, but the guidance that I've given for the year between 70 and 75% is still still accurate. Um, but, but, uh, in this quarter, it was probably closer to 70. Um, and was that the was there any, what was the second part of that question?
Yeah. How much of the 16% sequential growth is volume versus price.
but mostly buying
thank you.
Thank you. At this time. We've reached the end of the question and answer session. I'll turn the call over to Mike Weiss for closing remarks.
Excellent, thank you very much, operator. And thank you all again for joining us today. Uh, as you've heard this quarter highlights, the strength of our commercial execution, the growing demand for Bonnevie I'm significant opportunity ahead as we continue to expand our presence in Ms.
We Believe TG is well, positioned to drive meaningful near-term growth while also shaping the future of msk through differentiated options across IV subq and potentially self therapy laying the foundation for sustained growth and long-term shareholder value.
Most importantly, our Focus remains firmly on delivering for patients and we look forward to keeping you updated on our continued progress, in the quarters ahead,
Uh, thanks again for joining us and have a great day.
Thank you, this will conclude today's conference. Let me disconnect your lines at this time. Thank you for your participation.